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So, I have conversations about diet, exercise and weight loss every day in my practice. But it seems that sometime around Jan 1, those conversations are more often started by my patients. We are moving from the indulgent end of the year holiday season, to the fresh start of a new year. So it seems natural to try to start fresh- live healthier, better, richer…

Well, maybe not richer. But there are a lot of people getting richer of our desires to look and feel healthier. So there are a lot of theories about how we got her, and promises to do this one thing, cut out this, take this pill, and turn your life around. Face it, a quick fix seems pretty damn appealing to all of us. And I am in the pill pushing business. A big part of my job is to prescribe medicines. So with all of these conversations about losing weight, medicine is a frequent question.

So today, I’m going to build on a recent morning report lecture on obesity to focus on medical treatments for obesity. We’ll talk about old, new, tried and true and up and coming. I’ll try to highlight the evidence base for these so that you can discuss in an informed way with your patients.

I also want to start with a disclosure.. I almost never prescribe medicine for weight loss. My bias (and I’ll argue, the evidence) is that these are generally not that helpful, and almost always patients gain back weight, plus more, once they stop taking them. The studies that got these medicines approved were always coupled with a solid diet and exercise plan, and I think that most of the weight loss comes from that activity, NOT from the medicine.

Orlistat

Orlistat inhibits pancreatic lipases, so less fat is absorbed in digestion. In studies, patients on orlistat lost 5-10kg (compared to 3-6kg with diet/exercise alone). It also has been shown to lower blood pressure, and LDL levels more than would be expected by the weight loss alone. It is safe, as most of it remains un-absorbed. However, the main side effects are GI related: bloating, nausea, and diarrhea. These are generally pretty limiting, and I haven’t found many patients willing to even try orlistat after hearing these effects. However, if patients can stick to a low-fat diet, the effects can be minimized.

Phentermine

Phentermine is a stimulant that suppresses appetite. It is the oldest of the approved medicines for weight loss, and also one of the cheapest. It is approved for 12 weeks of therapy, so most studies are of short duration only. Studies show around 7kg of weight loss. Side effects include hypertension, tachycardia, anxiety, insomnia- in my experience these are pretty limiting.

There is a new medicine that combines phentermine with topiramate, Qsymia. The phentermine dose is lower than if prescribed separately, and it is approved for longer term use. The initial trial for this Rx showed patients lost 8-10 kg in the first year, and could maintain weight loss if they continued for another year. Only about 60% of patients took the Rx for the whole first year.

Topiramate

So what about just Topiramate itself? Currently topiramate is approved for treatment of epilepsy and migraine. Using it for weight loss is off label- so beware. However, it has been studied, and patients lost about 4kg over 6 months in the various trials.

Lorcaserin

Lorcaserin (Belviq) is a serotonin receptor agonist, and thus serves as an appetite suppressant. A few other serotonin agonists have been tried over the years- fenfluramine- and lead to cardiac valve disease. Lorcaserin is more specific to the 2C receptor, which should minimize cardiovascular effect. In trials, more patients on lorcaserin lost at least 5% of their body weight (mean 5kg). There were also decreases in BP, HR, LDL, CRP, and glucose. All of the trials had dropout rates close to 50%. Side effects include headache, nausea, URI sx, and back pain.

Diabetes Drugs:

Liraglutide (Victoza, Saxenda- same Rx, two brand names) is the one drug in this group with an indication for weight loss. In patients without diabetes, trials showed around 7kg of weight loss, and in one trial, patients who lost weight pre medicine were more likely to maintain the weight loss if on liraglutide. Side effects include nausea/vomiting/diarrhea and rarely, pancreatitis.

Metformin Old drug, lots of data on weight loss, but still no indication for obesity treatment. Why? Patients don’t tend to lose a lot of weight with metformin- about 2kg. But what different with metformin, is that there is long-term data that showed that patients could maintain that weight loss as long as they stayed on the Rx. And it decreases incidence of diabetes in these people as well. Certainly something to consider in obese patients with pre-diabetes or otherwise at high risk.

Bupropion

Another off label use here, but post marking data did show a tendency toward weight loss in patients on bupropion. Remember, this drug increases norepinephrine effect, so likely has some sympathomimetic benefits. In one short (6 month) trial, patients on bupropion lost 7-10% of their body weight (compared to 5% lost on placebo).

There is a brand new combo drug that uses Naltrexone and Bupropion (Contrave). Patients got about 5% weight loss over a longer study (56 weeks), but only about half of the patients were able to complete the study. Nausea, headache, and constipation were common side effects. There is also a cardiovascular concern that is being actively monitored in the post-marketing period.

Big Picture

Diet and exercise are the key- slow and steady wins the race. There may be some small incremental gains with the medicines above, but I think that the evidence is thin, there are clear side effects, and the risks are not always understood. Given the millions of Americans that could end up on these medicines, I’d prefer to hang back and wait for the fallout before becoming an early prescriber of any of these.

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Noon conference this week was about safe opiate prescribing. I hope that some of you were there and enjoyed it. As I was making the talk, I felt that I also wanted to learn/teach more about chronic pain and how to treat it.

Most of this information comes from a great TMS (no really) course on Complex Chronic Pain. If you are interested in the topic, I recommend the course. TMS is here, and you can find the course by searching for V07 Complex Chronic Pain Course. Of course you have to be a VA employee to access TMS.

Do you have patients in your clinic that carry a diagnosis of “Chronic Pain.” Not chronic back pain, or osteoarthritis, or fibromyalgia, but just “chronic pain.” It has been a pet peeve of mine, to label the pain but not the etiology, but turns out that it is a real thing, and our traditional biomedical model just doesn’t do a great job at addressing the issue. We start out with the right things: history and physical, careful testing, conservative treatment. When that doesn’t work, we might refer to a specialist, or PT, or send the patient for injections. Slowly we tread into unproven, non-evidence based therapies, which often don’t work either. Or, the patient feels a little better; often because they felt that they were heard and they believe in the treatment plan, not because the therapy worked. We keep doing the same things and expecting a different result. the patient feels that their life is on hold while their doctor gets their pain under control. Eventually, the patient gets frustrated with us, we get frustrated with the patient, and the relationship becomes strained. Often, the patient finds a new doctor and the cycle starts over again. We are all frustrated and unsatisfied, and we resolve not to do that again. But we do, because the tools we have are insufficient for the problem

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A new way to think about this is from a biopsychosocial model. The root cause of the pain is as much psychosocial and emotional as it is biological, and emotional and social stressors make it worse, just as lifting a refrigerator would. In this model, the doctor has to give up some control, it is really up to the patient to get better. We become the coach, the therapist, rather than the omniscient expert with the prescription pad. The goal shifts from relieving pain to restoring function and improving health. Patients move away from a focus on ending pain and minimizing symptoms to “expecting pain” and living their life in spite of that. The office visit is less about pain control and more about setting and achieving functional goals. Your job is to teach patients that you hear their frustration and believe that they have pain, but there isn’t a medical solution to this problem, and the two of you are going to work together to help them move on with their life.

there are no magic pills

Chronic pain is aggravated by a variety of things. If you can identify these in your patient, you may be able to help them move forward in recovery. The first is deconditioning: think like an athlete in spring training, they don’t expect to come in at mid-season form. Second is poor coping skills and ineffective stress managment techniques. We should teach that pain is not necessarily leading to more damage, but represents a bump in the road that they will move past. Pain is inevitable, but misery is optional. Finally, outright mood disorders can aggravate pain. It is reasonable to aggresively seek out and treat these, but in such a way so that the patient doesn’t come away feeling that you don’t believe their pain.

How to help the patient set goals. These need to come from the patient, not you. Ask about what they want to do, but can’t now. Listen carefully and pick up on anything that the patient identifies, then try and troubleshoot the barriers. If they want to exercise, but always have increasing pain, then try and reduce the intensity back to a level that they can acheive. Set goals that seem too easy, too simple, so that you can build on successes- first you have to have successes. If the patient is not even getting dressed every day, make that a first step. Later they can work toward the gym membership, but if you try and do it all at once, they will end up hurting and less likely to try again.

Goals need to be acheivable, almost easy for the patient. Then build on success.

If you have access, pain psychology or mental health providers can help with cognitive behavioral therapy around coping mechanisms, goal setting, and stress managment techniques. You can also teach your patient some simple stress managment. Deep breathing and meditation is a simple concept to understand and provides a coping strategy for the patient to deal with pain. There is an app “Breathe 2 Relax” that teaches deep breathing and website calm.com that does guided imagery relaxation.

The trick for all of this is getting patients to buy in. They are doing all of the work and the motivation has to come from within. So long as you really listen to their pain story, and have done an adequate evaluation, you don’t necessarily change the treatment plan because of resistance. However, don’t become confrontational, don’t fight. Pushing hard for patient self managment strategies will often backfire. Use your best Motivational Interviewing jujitsu to roll with resistance and put the onus to change back onthe patient. They can certainly stay the same, but you might point out that isn’t getting them anywhere.

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I’ve been hearing about JNC 8 for so long, that I thought it didn’t really exist. Thanks to some persistent hypertension experts, it is here at long last. Here’s a quick review of the major points. I’m sure that we will see some commentary in the days and weeks to come, I’ll try to keep you updated on that as well. I’d love to hear what you think- start the conversation in the comments below.

Higher BP targets

We are used to aiming for 140/90 for most people, and 130/80 for those with CKD, diabetes, CAD, and other comorbidities. But new evidence has emerged that these may not be so great, particularly for elderly patients. So JNC 8 says- Adults 18-60 (even with DM or CKD) should aim for BP <140/90. We can be a little more relaxed with patients over 60, and aim at 150/90 for them, so long as they don’t have CKD or DM. Most of this change comes because there really was no outcome data for our prior target, and it seems that getting people to the 140s systolic provides just as much benefit as the 130s range.

Relaxed first line medicine choices

We’ve known that this was coming for a while. JNC 7 recommended thiazides as first line for all, but there was never any real data to back that up. So JNC 8 says that we can use thiazides, ACE-I/ARBs, or calcium channel blockers as a first choice for most patients. They do acknowledge the racial difference in response to ACE inhibition, and recommend that we DON’T use ACE/ARB as first line for our black patients. EXCEPT (there’s always an exception) that for patients with chronic kidney disease (but not necessarily diabetes without ckd), use ACE-I first, no matter the race.

Second, and third, and fourth line medicines

Really not much different here, except there are not really recommendations about when to start two medicines at first visit. JNC 8 says we can pick a variety of treatment strategies– maximize one medicine at a time, add a second agent before maximizing the first, or start two medicines at once. When you add agents; pick from that first line list (thiazides, ACE/ARB, CCB) until you’ve used them all, then use aldosterone antagonists, beta blockers, central agents, or other vasodilators. They do recommend avoiding ACE-I and ARB combos for most patients.

What’s Missing

JNC 7 discussed prehypertension, secondary hypertension, resistant hypertension, adherence, how to measure blood pressure, and lots of other related issues. The JNC 8 group just picked 3 questions that they felt were most important: does starting treatment at a particular threshold improve outcomes, does a particular treatment goal improve outcomes, do various drugs have important differences in risk/benefit calculation and outcomes. Very evidence based and outcome oriented, which is kind of refreshing.

What about my patients now?

For all of us who have been trying to follow JNC 7 (and the subsequent performance measures created from that guideline), should we go adjusting therapy on our patients to meet new targets? No, say these experts. If your patient has a blood pressure of <150/90 on their current therapy, and is doing well, no need to change. Stay tuned to see if any of our performance targets change.

A great big picture algorithm from the JNC 8 group is here, and the link to the guidelines themselves is here (on the JAMA website subscription may be needed).